FDA.reportPublic FDA data

Cut Screw - Percutaneous Compression Screw

Primary DI
07899258659183
Brand
Cut Screw - Percutaneous Compression Screw
Company
GM DOS REIS INDUSTRIA E COMERCIO LTDA
Model
Cut Screw - Sterile
Catalog number
317-03-48S
Device description
CUT SCREW S Ø3.0 x 48.0mm
Published
2024-01-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230397000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230397000Cut Screw - Percutaneous Compression ScrewGM Dos Reis Industria e Comercio Ltda.2023-06-12HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899258659183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899258659183078992586591837899258659183

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended to be used for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, or used in dentistry/orthodontics, craniofacial or spinal bones. It is typically of cortical or cancellous design and has a drive (e.g., a slot, or of cross, star, or polygonal shape) at its proximal end for introduction with a screwdriver. It is made of non-bioabsorbable materials (e.g., metal).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
900865213
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07899258648729Orthopedic InstrumentsSELF-CENTERING BONE FORCEPS169-1642026-06-01
07901125602533Expert KnotlessExpert KnotlessFD0010102026-05-28
07899258650500Orthopedic InstrumentsREDUCTION FORCEPS JAW169-1652026-05-19
07899258699943Orthopedic InstrumentsT7 HEXALOBULAR DRIVER TIP 95mm223-308-F2026-05-19
07901125602502Orthopedic InstrumentsFRESA PARA PLACA DORSAL STT180-3802026-05-13
07901125602519Orthopedic InstrumentsFRESA PARA PLACA DORSAL CHTL 12F180-3812026-05-13
07901125602526Orthopedic InstrumentsFRESA PARA PLACA DORSAL CHTL 8F180-3822026-05-13
07899258601847Super Upper Limbs Versalock Plating SystemVERSALOCK LOCKING SCREW Ti T7 Ø2.4x11.0mm223-24-11-BP2026-04-08
07899258601854Super Upper Limbs Versalock Plating SystemVERSALOCK LOCKING SCREW Ti T7 Ø2.4x13.0mm223-24-13-BP2026-04-08
07899258601861Super Upper Limbs Versalock Plating SystemVERSALOCK LOCKING SCREW Ti T7 Ø2.4x15.0mm223-24-15-BP2026-04-08
07899258601878Super Upper Limbs Versalock Plating SystemVERSA TORXDRIVE MINI SCREW Ti Ø2.4x11.0mm223-24-11-C2026-04-08
07899258601885Super Upper Limbs Versalock Plating SystemVERSA TORXDRIVE MINI SCREW Ti Ø2.4x13.0mm223-24-13-C2026-04-08
07899258601892Super Upper Limbs Versalock Plating SystemVERSA TORXDRIVE MINI SCREW Ti Ø2.4x15.0mm223-24-15-C2026-04-08
07899258601908Super Upper Limbs Versalock Plating SystemVERSALOCK LOCKING SCREW Ti T7 Ø2.7x11.0mm223-27-11-BP2026-04-08
07899258601915Super Upper Limbs Versalock Plating SystemVERSALOCK LOCKING SCREW Ti T7 Ø2.7x13.0mm223-27-13-BP2026-04-08
07899258601922Super Upper Limbs Versalock Plating SystemVERSALOCK LOCKING SCREW Ti T7 Ø2.7x15.0mm223-27-15-BP2026-04-08
07899258601939Super Upper Limbs Versalock Plating SystemVERSA TORXDRIVE MINI SCREW Ti Ø2.7x11.0mm223-27-11-C2026-04-08
07899258601946Super Upper Limbs Versalock Plating SystemVERSA TORXDRIVE MINI SCREW Ti Ø2.7x13.0mm223-27-13-C2026-04-08
07899258601953Super Upper Limbs Versalock Plating SystemVERSA TORXDRIVE MINI SCREW Ti Ø2.7x15.0mm223-27-15-C2026-04-08
07899258612546Super Upper Limbs Versalock Plating SystemVERSALOCK TORXDRIVE MINI SCREW T6 Ø2.0x15.0mm308-20-15-B2026-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700569658212Xpert PFPNEWCLIP TECHNICSHWC2026-06-03
00842188131981CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188131998CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132001CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132018CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132025CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132032CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132049CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132056CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132063Tools - HCSTrimed, INC.HWC2026-06-02
00842188132070Tools - HCSTrimed, INC.HWC2026-06-02
07630894829819APTUSMedartis AGHWC2026-06-01
07630894829826APTUSMedartis AGHWC2026-06-01
07630894829833APTUSMedartis AGHWC2026-06-01
07630894829840APTUSMedartis AGHWC2026-06-01
07630894829857APTUSMedartis AGHWC2026-06-01
07630894829864APTUSMedartis AGHWC2026-06-01
07630894829871APTUSMedartis AGHWC2026-06-01
07630894829888APTUSMedartis AGHWC2026-06-01
07630894829895APTUSMedartis AGHWC2026-06-01
07630894829901APTUSMedartis AGHWC2026-06-01
07630894829918APTUSMedartis AGHWC2026-06-01
07630894829925APTUSMedartis AGHWC2026-06-01
07630894829932APTUSMedartis AGHWC2026-06-01
07630894829949APTUSMedartis AGHWC2026-06-01
07630894829956APTUSMedartis AGHWC2026-06-01
07630894829963APTUSMedartis AGHWC2026-06-01
07630894829970APTUSMedartis AGHWC2026-06-01
07630894829987APTUSMedartis AGHWC2026-06-01
07630894829994APTUSMedartis AGHWC2026-06-01